Biomedical Engineering Reference
In-Depth Information
Table 13.1
Multiparameter assays for breast cancer approved by regulatory agencies
Assay (company)
Method
Tissue type
Approval
Patient population
Prognosis/prediction
Mammaprint
70-Gene Assay
(Agendia)
DNA
Microarray
Fresh or
Frozen
Europe and US
(FDA)
ER-Pos/Neg stage I-II
breast cancer
Prognostic for distant recurrence
Oncotype DX
21-Gene Assay
(Genomic Health)
qRT-PCR FFPE
Europe and US
(CLIA)
ER-Pos stage I-II
breast cancer
Prognostic for distant recurrence
Predictive of chemotherapy benefit
if RS high
Theros H/I
SM
2-Gene Ratio
(Biotheranostics)
qRT-PCR FFPE
US (CLIA)
ER-Pos, Lymph node
Negative Breast
Cancer
Prognostic for distant recurrence
Theros MGI
SM
5-Gene Molecular
Grade
qRT-PCR FFPE
US (CLIA)
ER-pos, Grade 2
tumors
Prognosis - reclassification of
tumors from grade 2 to grade 1
or 3
